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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cannula, manipulator/injector, uterine
510(k) Number K180291
Device Name Cook Silicone Balloon HSG Catheter
Applicant
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Applicant Contact Yan Li
Correspondent
Cook Incorporated
750 Daniels Way, P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact Yan Li
Regulation Number884.4530
Classification Product Code
LKF  
Date Received02/01/2018
Decision Date 10/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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